Module 6

02/10/2024

Regulatory Pathway Mapping the journey to MAA

The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

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Regulatory Pathway Plan Key considerations from development to market

Post Launch Marketing

Market Research

Clinical Studies

Regulatory Approval

Product Launch

Develop a Project Plan: Map the Regulatory Journey from Development to the Market Place

Provide regulatory background on disease area, competitors labels and clinical study design

Input into clinical development program Request and prepare for scientific advice

MAA submission and assessment to desired TPP

Launch Ready

Assure licence obligations and post approval commitments Manage product life cycle / future changes to the licence or label

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Assist with HTAs

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Review and finalise promotion and advertising materials

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PIP compliance check

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Input in TPP

Orphan Maintenance (if applicable) Input on product Labelling to desired TPP

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Develop global regulatory strategy and filing plan

Implement label

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Clinical guidelines

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PIP Obligations

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Post-approval plans

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PRIME (if applicable)

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Input into launch plans including drug product and packaging readiness

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Orphan (if applicable)

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Tradename

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The Organisation for Professionals in Regulatory Affairs

Lecture 1: Part 1 – Develop and Shape the Brand

24

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